Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-intensity laser therapy (HILT)
Sham laser
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring High-intensity, pain, knee osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients with primary knee OA diagnosed based on the American college of rheumatology (ACR) guidelines for early diagnosis of knee osteoarthritis 2016.
- Patients who had knee pain for at least 6 months and had VAS score greater than 4 out of 10 points
- Patients with knee OA who have Kellgren And Lawrence (KL) classification stages 2-4.
Exclusion Criteria:
- Patients who have secondary knee OA caused by other pathologies
- Patients who have a history of corticosteroid or hyaluronate injecting into the knee joint within the past 6 months
- Patients who were treated by physical therapy equipment within 1 month before the study
- History of stroke, bleeding disorders, cancer, deep vein thrombosis, cognitive impairment, or mental disorders
- Contraindicate to laser therapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
High-intensity laser therapy (HILT)
Sham laser
Arm Description
The participants in the intervention group were treated by HILT which was applied to the knee joint (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.
The control group received a sham laser by the same laser machine (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
VAS is the standardized pain measurement which allows subjects to rate pain score by using the ruler scale. This pain scale starts from 0 which means no pain to 10 which means maximum pain.
Secondary Outcome Measures
Thai version of the Western Ontario and McMaster (WOMAC) Osteoarthritis Index for knee osteoarthritis (T-WOMAC)
WOMAC score is the questionnaire used to assess pain and function in patients with knee OA. This score consists of 3 subscale including pain, function and joint stiffness. The total scores of all subscales are 96 points in which the higher score reflects the more disabled of the patient. For Thai version of WOMAC, this score has been proven valid for using in patients with knee OA.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04889885
Brief Title
Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis
Official Title
Short Term Efficacy of High-intensity Laser Therapy to Alleviate Pain in Patients With Knee Osteoarthritis: a Double-blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Knee osteoarthritis (KOA) is one of the most common health problems around the world. According to this, several interventions have been used to treat this group of patients including pharmacological and non-pharmacological management such as weight reduction, behavior modification, and physical therapy. Recently, high-intensity laser therapy (HILT) has been used to treat patients with KOA. The results of previous studies showed that HILT could help to reduce pain as well as improved function in patients with mild to moderate KOA. However, there were still no standardized guidelines for HILT treatment in KOA. Also, no previous studies evaluated the efficacy of HILT in patients with severe KOA. The present study, therefore, recruited not only mild to a moderate degree but also severe degree. The study aim was to determine the efficacy of HILT in terms of pain relief in patients with mild, moderate, and severe KOA. The hypothesis was HILT would effectively reduce pain in patients with KOA compared to sham laser plus conservative treatment.
Detailed Description
This study is a double-blinded randomized control trial that compared the efficacy of HPLT to sham laser in patients with KOA.
42 patients who had KOA diagnosed by the American college of rheumatology (ACR) 2016 guidelines were recruited including a drop out of 20%.
The participants were then randomly allocated into two groups (21 participants per group), mainly HILT and sham laser. Also, both groups received conservative treatment such as disease education, exercise, and advice for weight reduction.
The intervention group received HILT which was applied on the medial, lateral, and posterior part of the knee joint. The total energy was 562.5 J per session which was done 2-3 sessions a week, for a total of 10 sessions.
The control group received sham laser by the same device for 10 sessions plus conservative treatment as in the intervention group.
The outcome measures, VAS and T-WOMAC score were recorded before and at the end of the study.
Statistical analysis was performed using SPSS 18.0 version to evaluate the statistically significant change within the same group and the difference between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
High-intensity, pain, knee osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-intensity laser therapy (HILT)
Arm Type
Experimental
Arm Description
The participants in the intervention group were treated by HILT which was applied to the knee joint (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.
Arm Title
Sham laser
Arm Type
Sham Comparator
Arm Description
The control group received a sham laser by the same laser machine (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.
Intervention Type
Device
Intervention Name(s)
High-intensity laser therapy (HILT)
Other Intervention Name(s)
High-power laser therapy (HPLT)
Intervention Description
HILT was done by Multiwave Locked System (MLS) laser therapy combining 2 laser wavelengths (808 and 905 nm) in order to strengthen the effects of HILT. The laser was applied on medial, lateral and posterior parts around the knee joint. The total energy per session was 562.5 Joules (J) which was done 2-3 times a week for a total of 10 sessions.
Additionally, the participants received conservative treatment for knee OA such as education about the disease, proper activities, and exercise.
Intervention Type
Device
Intervention Name(s)
Sham laser
Intervention Description
The control group received a sham laser (2-3 times a week for a total of 10 sessions) plus conservative treatment as in the intervention group. The laser machine was the same as in the intervention group; however, the laser was applied without releasing laser energy to the knee joint.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
VAS is the standardized pain measurement which allows subjects to rate pain score by using the ruler scale. This pain scale starts from 0 which means no pain to 10 which means maximum pain.
Time Frame
VAS was recorded in the two time points. The first time point was at the baseline or before starting the treatment. After that, VAS was recorded post-intervention (at 4 weeks from baseline) as the second time point.
Secondary Outcome Measure Information:
Title
Thai version of the Western Ontario and McMaster (WOMAC) Osteoarthritis Index for knee osteoarthritis (T-WOMAC)
Description
WOMAC score is the questionnaire used to assess pain and function in patients with knee OA. This score consists of 3 subscale including pain, function and joint stiffness. The total scores of all subscales are 96 points in which the higher score reflects the more disabled of the patient. For Thai version of WOMAC, this score has been proven valid for using in patients with knee OA.
Time Frame
T-WOMAC was recorded in the two time points. First, T-WOMAC was recorded at the baseline and was then recorded post-intervention (at 4 weeks from baseline) as the second time point.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with primary knee OA diagnosed based on the American college of rheumatology (ACR) guidelines for early diagnosis of knee osteoarthritis 2016.
Patients who had knee pain for at least 6 months and had VAS score greater than 4 out of 10 points
Patients with knee OA who have Kellgren And Lawrence (KL) classification stages 2-4.
Exclusion Criteria:
Patients who have secondary knee OA caused by other pathologies
Patients who have a history of corticosteroid or hyaluronate injecting into the knee joint within the past 6 months
Patients who were treated by physical therapy equipment within 1 month before the study
History of stroke, bleeding disorders, cancer, deep vein thrombosis, cognitive impairment, or mental disorders
Contraindicate to laser therapy
12. IPD Sharing Statement
Citations:
PubMed Identifier
36313402
Citation
Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.
Results Reference
derived
Learn more about this trial
Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis
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